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Vietnam Amends Medical Device Regulations – 2019
The Government of Vietnam, at the proposal of the Minister of Healthcare, has published a decree amending and supplementing national medical device regulations. The proposed amendments aim to modify a wide scope of...
Health Canada Issues Guidance on SaMD
Health Canada, the Canadian medical device regulating agency, has issued new guidance on software as a medical device (SaMD) to provide details on definition and classification.  The Scope of the Guidance   The new...
The MDCG’s Class II Medical Device Guidance
The Medical Device Coordination Group (MDCG), the advisory body assisting the European Commission on issues related to the implementation of legislation regulating the circulation of medical devices, has published...
AEMPS Provides Additional Time to Change Labels
The Spanish Agency of Medicines and Medical Devices (AEMPS) announced the extension of the period provided for medical device manufacturers to implement changes to labeling required due to Brexit. A General Overview of...